Study design & results
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Trial intelligence / Profile preview
Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis
2024-520373-12-00Phase 4Authorised
- Sponsor
- Varsinais-Suomen hyvinvointialue
- Start
- Jan 2025
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Countries
- 1
01
Overview
Phase 4, randomised trial of infliximab, vedolizumab and allogeneic fecal microbiota in autoimmune colitis (2 arms), sponsored by Varsinais-Suomen hyvinvointialue. Primary endpoint: Steroid-free clinical remission at week 14 from first fecal microbiota transplant and week 12 from first infliximab/vedolizumab infusion. Planned start Jan 2025; status: authorised.
02
Drugs
infliximabvedolizumaballogeneic fecal microbiota
03
Conditions
autoimmune colitis
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